Iron Absorption From a Nutritional Iron Supplement
Conventional oral iron supplements often cause gastrointestinal side effects and are limited by poor bioavailability, leaving unabsorbed iron to reach the colon. Hydrocolloid-based hydrogel matrix formulations designed for gradual iron release present a promising approach to improve iron absorption. This study evaluates fractional iron absorption (FIA) from three low-dose hydrogel formulations containing ferrous fumarate compared with ferrous fumarate without a hydrogel matrix. Test products will be administered with water, with and without a standardized breakfast. All formulations will be intrinsically labelled with stable iron isotopes ( 57Fe or 54Fe), and FIA will be determined 14 days after administration based on erythrocyte iron incorporation. In this randomized, within-subject corssover study conducted in non-anemic, iron-depleted women, each participant will receive all test conditions and serve as her own control.
Studieöversikt
Status
Betingelser
Intervention / Behandling
- Kosttillskott: Iron-Enriched Hydrogel Supplement (A with breakfast)
- Kosttillskott: Iron-Enriched Hydrogel Supplement (B with breakfast)
- Kosttillskott: Iron-Enriched Hydrogel Supplement (A without breakfast)
- Kosttillskott: Iron-Enriched Hydrogel Supplement (B without breakfast)
- Kosttillskott: Iron-Enriched Hydrogel Supplement (C with breakfast)
- Kosttillskott: Control (FeFum, with breakfast)
- Kosttillskott: Control (FeFum, without breakfast)
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Camarena
- Telefonnummer: +41446328393
- E-post: seline.camarena@pharma.ethz.ch
Studieorter
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Schweiz, 8006
- Rekrytering
- ETH Zürich, Laboratory of Clinical Biopharmacy
-
Kontakt:
- Camarena
- Telefonnummer: +41446328393
- E-post: seline.camarena@pharma.ethz.ch
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Female aged 18 to 45 years
- Plasma ferritin <30 µg/L
- Body mass index (BMI) 18.5 kg/m2 - 24.9 kg/m2.
- Body weight <65 kg.
- Signed informed consent
- Sufficient command of English (mother tongue or B2 level)
Exclusion Criteria:
- Anemia, defined as hemoglobin (Hb) <120 g/L (<12.0 g/dL).
- Elevated systemic inflammatory markers (C-reactive protein >5.0 mg/L).
- Chronic digestive, renal and/or metabolic diseases
- Chronic medications (except for contraceptives)
- Use of vitamin, mineral, or pre-/Pprobiotic supplements in the 2 weeks before or during the study
- Blood transfusion, blood donation or significant blood loss (>400ml) over the past 4 months
- Difficulty with blood withdrawal
- Pregnancy (tested in serum/urine) or intention to become pregnant during the course of the study
- Lactation
- Previous participation in a study using stable isotopes or participation in any clinical study within the last 30 days
- Participants who cannot be expected to comply with the study protocol (e.g. not available on certain study appointments)
- Inability to understand the information sheet and the informed consent form due to cognitive or language reasons
- Smoking (>1 cigarette/week)
- Vegan diet (the standardized breakfast contains plain whole milk yogurt and butter)
Special exclusion criteria for participants in the MRI imaging sub-study (n=9):
- Presence of a heart pacemaker, neurostimulator, or any other active implanted electronic device.
- Use of a hearing aid that cannot be safely removed for the MRI examination.
- Use of removable dentures that cannot be safely removed for the MRI examination.
- History of surgery on the head or heart involving implanted material that is not confirmed MRI-safe.
- Presence of metallic objects in the body (e.g. implants, magnets, metal splinters, gunshot fragments, tattoos, piercings, or surgical clips) that are not confirmed MRI-safe.
- History of metal splinter injury (e.g. ocular foreign body) or occupational exposure associated with increased risk of retained metal fragments.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: FeHydro-A with breakfast (Condition 1)
FeHydro-A with sodium ascorbate, consumed with a standardized breakfast |
FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast
Andra namn:
|
|
Experimentell: FeHydro-B with breakfast (Condition 2)
FeHydro-B without sodium ascorbate, consumed with a standardized breakfast |
FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast
Andra namn:
|
|
Experimentell: FeHydro-A without breakfast (Condition 3)
FeHydro-A with sodium ascorbate, consumed without breakfast |
FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water |
|
Experimentell: FeHydro-B without breakfast (Condition 4)
FeHydro-B without sodium ascorbate, consumed without breakfast |
FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water |
|
Experimentell: FeHydro-C with breakfast (Condition 5)
FeHydro-C with sodium ascorbate and gum arabic, consumed with a standardized breakfast |
FeHydro-C (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast |
|
Aktiv komparator: Control with breakfast (Condition 6)
Control ferrous fumarate, consumed with a standardized breakfast |
Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + Standardized Breakfast |
|
Aktiv komparator: Control without breakfast (Condition 7)
Control ferrous fumarate, consumed without breakfast |
Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + 300 mL Water |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fractional Iron Absorption
Tidsram: 14 days after administration of each labelled test condition
|
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in red blood cells |
14 days after administration of each labelled test condition
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRONH
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Individual participant data (IPD) will not be made publicly available to protect participant privacy and maintain confidentiality regarding proprietary formulation data. De-identified, aggregated study results and primary outcome data will be published in peer-reviewed scientific journals and made available via public study registries upon completion of the trial.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .